Services

Pharmacovigilance

Norwich Clinical Services’ (NCS') pharmacovigilance, product surveillance and drug safety support services cover the entire product life cycle from development, through pre and post-marketing stages. The NCS team is your reliable partner in reaching compliance and maximal effectiveness of your pharmacovigilance/surveillance system and covering the complex regulatory requirements.

Our Pharmacovigilance/surveillance activities are in compliance with the FDA and the latest EU Guidance.

NCS PV Info

SOFTWARE USED

Siemens Open Scape call center solutions for our 24 hour call center

For adverse event reporting

MedDRA coding

Axway Synchrony for regulatory submission

XEVMPD

Capabilities & Expertise

SAFETY DATABASE

NCS has 21 CFR (part 11) and EudraVigilance compliant pharmacovigilance database for complete adverse event management in the pre and post marketing setting. We undertake database creation and maintenance on behalf of our clients. The database is accessible to our sponsors and EU QPPV located within the EEA.

ELECTRONIC SUBMISSION OF CASES TO REGULATORY AGENCIES USING ELECTRONIC GATEWAY

Expedited reporting of cases to EudraVigilance and FDA using electronic gateways. We have also set up electronic gateways with EU countries and FDA.

24/7 CALL CENTER ACTIVITIES: SAFETY & MEDICAL INFORMATION

At NCS we have a team of trained, skillful support specialists. The tasks carried out by this team include the dissemination of accurate, specific, timely and organized medical information in response to the queries by consumers and health care professionals. The tasks of the medical safety team include receiving the adverse events details from consumers and health provider as well as proactively initiating routine follow ups. The adverse events received are processed according to ICSR guidelines. The triaged date is entered into the database along with the respective dates for action and closure. All follow up attempts and any information collected are recorded. Monthly reconciliation reports are sent out as per contracted terms.

SIGNAL DETECTION

Routine and proactive signal detection activities using validated software tools on the PV database by semi-automated methodologies. Manual searches, review and analysis will be carried out by the team of health care professionals and statisticians.

RISK-BENEFIT ANALYSIS

A comprehensive review, analysis and report of risk benefit analysis will be carried out by system specialists.

RISK MANAGEMENT PLAN, RISK MINIMIZATION ACTION PLAN

A comprehensive review, analysis and report generation will be carried out by our health care professionals and statisticians for the following: